Scope of FDA’s power over AI an ‘unsettled’—and unsettling—question
The lead story in Tuesday’s Politico Pulse newsletter will feel familiar to anybody struggling to keep up with the ever-changing AI landscape.
Unfortunately, the subject of this story is the FDA, whose lack of resources to keep up with AI advancement is hindering the agency’s ability to serve its role as regulator.
“Rather than issuing a one-time approval, FDA wants to monitor artificial intelligence products over time, something it’s never done proactively,” writes health-tech reporter Ruth Reader.
Moreover, the FDA doesn’t have authority over systems that perform some administrative tasks, like summarizing physician notes.
Reader writes:
The FDA does regulate first-gen AI tools as it does medical devices, and 14 months ago Congress granted the agency the power to allow makers of devices, some of which include early AI, to implement preplanned updates without having to reapply for clearance.
But the scope of FDA’s powers over AI are unsettled.
Read the full story here.
Evan joined TriMed in 2011, writing primarily for Health Imaging. Prior to diving into medical journalism, Evan worked for the Nine Network of Public Media in St. Louis. He also has worked in public relations and education. Evan studied journalism at the University of Missouri, with an emphasis on broadcast media.